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Aileron Therapeutics, Inc. (NASDAQ: ALRN) is a clinical-stage biopharmaceutical company pioneering the development of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Located in Boston, Massachusetts, Aileron is leading the front in peptide therapeutics, focusing on innovative treatments for severe diseases.
The company’s flagship product is ALRN-6924, a unique chemoprotective agent designed to reactivate p53-mediated tumor suppression. Currently under multiple clinical trials, ALRN-6924 targets both MDMX and MDM2 proteins, pivotal in restoring the p53 function, often referred to as the “guardian of the genome,” due to its significant role in cancer prevention.
Another promising candidate is LTI-03, a novel Caveolin-1-related peptide in development for treating idiopathic pulmonary fibrosis (IPF). It is in a Phase 1b clinical trial, with results expected in the second quarter of 2024. Additionally, LTI-01 is a proenzyme under clinical evaluation for treating loculated pleural effusions, having completed Phase 1b and Phase 2a trials.
In the wake of challenging results from a Phase 1b breast cancer trial of ALRN-6924, leading to its termination, Aileron has been exploring strategic alternatives to maximize shareholder value. Recently, the company acquired Lung Therapeutics, Inc., integrating a pipeline of therapies targeting orphan pulmonary diseases.
The company remains well-funded, following an $18 million acquisition-financing round, bolstering its financial stability to propel ongoing clinical trials and corporate initiatives. As Aileron transitions under new leadership, with Dr. Brian Windsor as CEO, it continues to prioritize advancing its therapeutic candidates toward commercialization.
Visit aileronrx.com for more information about their groundbreaking research and future developments.
Aileron Therapeutics (NASDAQ: ALRN) reported positive clinical proof-of-concept data from its ongoing Phase 1b trial of ALRN-6924, demonstrating protection against severe anemia, thrombocytopenia, and neutropenia in p53-mutated small cell lung cancer patients treated with topotecan. The study showcased robust protection at a 0.3 mg/kg dosage. The company plans to initiate a Phase 1b trial in non-small cell lung cancer in Q2 2021 and is exploring a flexible dosing schedule. Financially, Aileron reported a net loss of $5.0 million for Q3 2020, with $14.1 million in cash as of September 30, 2020.
Aileron Therapeutics announced promising results from its ongoing Phase 1b trial of ALRN-6924, aimed at protecting patients with p53-mutated small cell lung cancer from chemotherapy-induced toxicities. The trial demonstrated that treatment with ALRN-6924 prior to topotecan significantly reduced severe anemia, thrombocytopenia, and neutropenia. Specifically, the 0.3 mg/kg dose showed the best results, limiting Grade 3/4 toxicities to 21%, 36%, and 43%, respectively. Aileron plans to expand clinical development to other p53-mutated cancers and will discuss the findings in an upcoming conference call.
Aileron Therapeutics (ALRN) will host a conference call on October 26, 2020, at 8:30 a.m. ET to discuss data from a Phase 1b study of ALRN-6924, a unique therapy aimed at preventing chemotherapy-induced myelosuppression in patients with p53-mutated cancers. Results will be presented at the EORTC-NCI-AACR Annual Symposium. ALRN-6924 is notable as the only chemoprotective therapy in development utilizing a biomarker approach, designed to shield healthy cells while allowing chemotherapy to target cancer cells.
Aileron Therapeutics (Nasdaq: ALRN) has announced data from its Phase 1b study of ALRN-6924, which aims to prevent chemotherapy-induced side effects in patients with p53-mutated small cell lung cancer (SCLC). The therapy utilizes a novel biomarker strategy to protect healthy cells while allowing chemotherapy to target cancer cells. A late-breaking poster presentation of the study will occur at the ENA 2020 Symposium. Aileron aims to expand chemoprotection across multiple cancer types, and an investor call is scheduled for October 26, 2020, to discuss the findings and future strategies.
Aileron Therapeutics (NASDAQ: ALRN) announced a common stock purchase agreement with Lincoln Park Capital Fund for up to $15 million. LPC made an initial investment of $500,000 at $1.36 per share. Aileron has the option to sell additional shares over 36 months, subject to SEC registration. Proceeds will support ALRN-6924's clinical development. The agreement allows Aileron to terminate without penalty, with no short selling or derivatives involved. This funding is intended to extend Aileron's cash runway for ongoing projects.
Aileron Therapeutics (NASDAQ: ALRN) announced a corporate presentation by CEO Manuel Aivado at the H.C. Wainwright Virtual Global Investment Conference on September 14, 2020, at 2:00 PM ET. The presentation will cover advancements in chemoprotection for patients with p53-mutated cancers, regardless of cancer type or chemotherapy. A live webcast will be available on Aileron's website, with a replay archived for 30 days. The company focuses on ALRN-6924, a dual MDM2/MDMX inhibitor aimed at improving chemotherapy outcomes and reducing side effects for around 50% of cancer patients.
Aileron Therapeutics (NASDAQ:ALRN) continues development of ALRN-6924, a chemoprotective medicine targeting chemotherapy-induced toxicities, with positive interim data from its Phase 1b study. Highlights include completed enrollment in the dose optimization expansion cohort and initiation of the schedule optimization phase. The company raised $10.3 million from a public offering in June 2020, enhancing its cash position to $18.9 million. The net loss for Q2 2020 was $4.4 million, lower than last year's $7.2 million, reflecting cost-saving measures.
Aileron Therapeutics (NASDAQ: ALRN) announced that CEO Manuel Aivado will take part in two investor conferences in August 2020. The first event is the William Blair Biotech Focus Conference on August 6 at 12:00 pm ET, featuring a fireside chat. The second event is the Canaccord Genuity 40th Annual Growth Conference on August 13 at 4:30 pm ET, where Aivado will provide a company overview and business update. Live webcasts will be available on Aileron's website, and recordings will be archived for 30 days.
Aileron focuses on advancing ALRN-6924, a treatment aimed at reducing chemotherapy side effects.
Aileron Therapeutics (NASDAQ: ALRN) has enrolled its first patient in the Phase 1b schedule optimization part of its clinical trial for ALRN-6924, aimed at protecting patients with p53-mutant extensive disease small cell lung cancer from chemotherapy-induced toxicities. The trial assesses whether administering ALRN-6924 six hours before chemotherapy enhances protective effects compared to a 24-hour schedule. With p53 mutations present in about 50% of cancer patients, ALRN-6924 has the potential to transform chemotherapy treatment by preserving healthy cells and improving patient quality of life.
Aileron Therapeutics (NASDAQ: ALRN) has successfully closed a public offering of 10,162,059 shares of common stock, including an additional 1,071,149 shares exercised by underwriters, at a price of $1.10 per share. This offering generated gross proceeds of $11.2 million prior to deductions. The funds will be utilized for the clinical development of ALRN-6924 as a chemoprotective agent and for general corporate purposes. William Blair & Company acted as the sole book-running manager for the offering, which was conducted under an effective registration statement filed with the SEC.
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